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Recruiting NCT07484490

Effects of the Active Cycle of Breathing Technique With and Without Balloon Blowing Therapy in Tuberculosis

No phase Interventional Tuberculosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active cycle of breathing with Balloon therapy, Active Cycle of breathing.
Who it may be relevant to
Registry conditions: Tuberculosis. Basic parameters: 8 years — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Effects of the Active Cycle of Breathing Technique With and Without Balloon Blowing Therapy on Sputum Secretion, Dyspnea, and Functional Capacity in Children With Tuberculosis

Overview

The study design will be a randomized controlled trial. The data will be collected from Gulab Devi Teaching Hospital, Lahore. 34 kids aged 8 to 14 years will be randomly assigned either to an experimental group or a control group. The intervention group includes the active Cycle of Breathing technique with balloon-blowing therapy for 3 days. The control group includes the active cycle of breathing technique. Sputum secretion will be measured by 'sputum measurement cups." Dyspnea will be measured by the "Modified Borg dyspne Scale," and functional capacity will be measured by the "6-Minute Walk Test." Data will be analyzed through SPSS version 25.0.

Detailed description

Pulmonary Tuberculosis (TB) is still a major health concern, especially in underdeveloped nations. Poor lung function, sputum retention, and dyspnea are common in children with tuberculosis (TB), which can limit their physical activity and quality of life. Physiotherapy treatments are essential for controlling these problems. An effective airway clearance technique that improves ventilation and mucus mobilization is the Active Cycle of Breathing Techniques (ACBT). Similarly, balloon therapy has been shown to strengthen respiratory muscles and alleviate dyspnea. Both interventions are low-cost, non-invasive, and feasible for implementation across diverse clinical and community settings. Although these therapies are successful when used separately, their combined effect on the therapy of pediatric tuberculosis has not been fully investigated. The aim of this study is to investigate the Effect of the Active cycle of breathing technique with and without balloon blowing therapy on sputum secretion, dyspnea and functional capacity in children with tuberculosis The study design will be a randomized controlled trial. The data will be collected from Gulab Devi Teaching Hospital, Lahore. 34 kids aged 8 to 14 years will be randomly assigned either to an experimental group (n=17) or a control group (n=17). The intervention group includes the active Cycle of Breathing technique with balloon-blowing therapy for 3 days. The control group includes the active cycle of breathing technique. Sputum secretion will be measured by 'sputum measurement cups." Dyspnea will be measured by the "Modified Borg Scale," and functional capacity will be measured by the "6-Minute Walk Test." Data will be analyzed through SPSS version 25.0.

Interventions

  • Other Active cycle of breathing with Balloon therapy
    ACBT will be administered twice daily, with each session lasting 10 minute for 3 days (25). It consists of following phases 1. Breathing Control (1-2 min): • participants will uses diaphragmatic breathing. • During this stage, the shoulders and upper chest of participants are relaxed alongside the lower chest to maintain a regular breathing rhythm and tidal volume. • With both hands on the abdomen, the patient inhales through the nose and exhales to assist relax the airways through the oral open
  • Other Active Cycle of breathing
    ACBT will be administered twice daily, with each session lasting 10 minute for 3 days (25). It consists of following phases 1. Breathing Control (1-2 min): • In this stage the participants will uses diaphragmatic breathing. • During this stage, the shoulders and upper chest of participants are relaxed alongside the lower chest to maintain a regular breathing rhythm and tidal volume. • With both hands on the abdomen, the patient inhales through the nose and exhales to assist relax the airways thr

Primary outcome measures

  • Sputum meauring cups [Time frame: Baeline,3day]
  • 6 minute walk test (6-MWT) [Time frame: baseline,3day]
  • Modified Borg Dyspnea Scale [Time frame: Baeline,3day]

Eligibility criteria

Inclusion criteria

  • Children aged 8 to14 years
  • Diagnosed with tuberculosis
  • Patients with excessive pulmonary secretions and/or difficulty clearing airway secretions.
  • Adequate cognitive ability to understand and follow verbal commands and perform ACBT.
  • Informed consent from parent/guardian

Exclusion criteria

  • Diagnosed with multi-drug-resistant (MDR) TB
  • Presence of hemoptysis
  • The patient who is unconscious and unresponsive.
  • Received physical therapy intervention in the past 2 weeks

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Other

Study locations

Pakistan · 1 center
  • Gulab Devi Hospital — Lahore

Publications

  • Misra A, Pawar R, Pal A. Effect of Balloon-Blowing Exercise on Oxygen Saturation in COVID-19 Patients. Cureus. 2023 Jun 11;15(6):e40250. doi: 10.7759/cureus.40250. eCollection 2023 Jun. PMID 37440814
  • Aytac S, Ovayolu O, Dogru S. The effect of breathing exercises on fatigue in tuberculosis patients: a randomized controlled trial. Rev Assoc Med Bras (1992). 2024 Dec 2;70(12):e20240888. doi: 10.1590/1806-9282.20240888. eCollection 2024. PMID 39630726

Identifiers

NCT: NCT07484490 · REC/RCR&AHS/NAYAB

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗